Comparison · NCT05136885-sae
SLS-005 vs Matching Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. SLS-005 vs Matching Placebo: serious adverse events. Trial comparisons, record NCT05136885-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05136885-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.158 | 0.104 | 0.234 | wilson | |
| Risk in group 2 | 0.0732 | 0.0252 | 0.194 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0852 | -0.0477 | 0.175 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.16 | 0.675 | 6.94 | log | |
| Odds ratio, group 1 over group 2 | 2.38 | 0.667 | 8.51 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SLS-005 than on Matching Placebo | 11.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SLS-005 | SLS-005 is administered via infusion once weekly for 24 weeks.~SLS-005: Administration: Infusion Dose: 0.75 g/kg weekly | 19 | 120 | EG000 |
| Group 2 | Matching Placebo | Matching placebo is administered via infusion once weekly for 24 weeks.~Matching Placebo: Administration: Infusion Dose: equivalent weight-based volume as described for trehalose | 3 | 41 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 35 weeks after participant signed Master Protocol consent.
Source ClinicalTrials.gov
Trial
- Title
- HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose
- NCT number
- NCT05136885
- Phases
- PHASE2, PHASE3
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- SLS-005, Matching Placebo
- Lead sponsor
- Merit E. Cudkowicz, MD
- Results first posted
- 2024-08-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05136885?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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